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Millions of Cartons of Eye Drops Recalled Nationwide
Millions of cartons of eye drops and other eye care products have been voluntarily recalled due to serious manufacturing and quality control issues. This widespread recall, impacting an estimated 1.8 million cartons, has prompted urgent warnings for consumers to stop using the affected products immediately. The recall involves several popular over-the-counter (OTC) eye products distributed by AvKARE, a prominent healthcare distributor, and affects millions across the country.
What Eye Products Are Recalled?
The recall encompasses five different ophthalmic solutions manufactured by BRS Analytical Service, LLC, and distributed by AvKARE between May 26, 2023, and April 21, 2025. The affected products are:
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)
The FDA audit revealed Current Good Manufacturing Practice (cGMP) deviations and a lack of assurance of sterility, raising concerns about the products' quality and potential risks to users. While no adverse events have been reported yet, the potential for eye infections or vision problems necessitates immediate action. The companies involved stress the importance of ceasing use immediately.
Why the Recall?
The recall stems from violations of cGMP standards discovered during a U.S. Food and Drug Administration (FDA) audit of BRS Analytical Service, LLC, the manufacturer. These deviations could result in products that don't meet quality standards, posing a potential health risk. The FDA has categorized this as a Class II recall, meaning the products "may cause temporary or medically reversible adverse health effects." The exact nature of the manufacturing issue remains unspecified, but the lack of sterility assurance is a significant concern.
This recall comes at a particularly sensitive time, coinciding with a worsening allergy season that has seen increased demand for eye drops to alleviate symptoms. The increased use of eye drops during allergy season further underscores the urgency of this recall.
What to Do If You Have Recalled Eye Drops
If you possess any of the recalled products, stop using them immediately. AvKARE is offering full credit, including return shipping costs. To receive a refund, complete the "Quantity to Return" section and customer information block on the recall notice and fax it to 931-292-6229 or email it to customerservice@avkare.com. Even if you've already used the product or no longer have it, AvKARE requests that you still submit the form.
Conclusion
This nationwide recall of millions of cartons of eye drops highlights the crucial role of rigorous manufacturing practices in ensuring consumer safety. The lack of transparency regarding the exact nature of the issue serves as a reminder of the importance of carefully reviewing products and promptly following recall notices. Protect your eye health: If you have any of the recalled products, take immediate action to cease use and seek a refund. This situation underscores the importance of vigilant oversight and transparent communication in the pharmaceutical industry.
